CeeNU has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in the following:

Brain tumors:   both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures.

Hodgkin's Disease:   secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.

The recommended dose of CeeNU in adult and pediatric patients as a single agent in previously untreated patients is 130 mg/m ² as a single oral dose every 6 weeks. In individuals with compromised bone marrow function, the dose should be reduced to 100 mg/m ² every 6 weeks. When CeeNU is used in combination with other myelosuppressive drugs, the doses should be adjusted accordingly.

Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment:

A repeat course of CeeNU should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/ mm ³ ; leukocytes above 4000/mm ³ ) and this is usually in 6 weeks. Adequate number of neutrophils should be present on a peripheral blood smear. Blood counts should be monitored weekly and repeat courses should not be given before 6 weeks because the hematologic toxicity is delayed and cumulative.

The dose pack of CeeNU® (lomustine)

NDC 0015-3034-10 Capsules contains:

2-100 mg capsules (Green/Green)

2-40 mg capsules (White/Green)

2-10 mg capsules (White/White)

Stability:   CeeNU Capsules are stable for the lot life indicated on package labeling when stored at room temperature in well closed containers. Avoid excessive heat (over 40°C, 104°F).

Directions to the Pharmacist:   The dose pack contains a total of 300 mg and will provide enough medication for titration of a single dose. The total dose prescribed by the physician can be obtained (to within 10 mg) by determining the appropriate combination of the enclosed capsule strengths.

The appropriate number of capsules of each size should be placed in a single vial to which the patient information label (gummed label provided) explaining the differences in the appearance of the capsules is affixed. Each color-coded capsule is imprinted with the dose in milligrams.

A patient information sticker, to be placed on dispensing container, is enclosed.

Also available:   Individual bottles of 20 capsules each.

NDC 0015-3032-20 100 mg capsules (Green/Green)

NDC 0015-3031-20 40 mg capsules (White/Green)

NDC 0015-3030-20 10 mg capsules (White/White)

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. ^1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; 253 (11):1590-1592.
3. National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
4. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428.
5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians 1983; (Sept/Oct)258-263.
6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47:1033-1049.
7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA WORK PRACTICE GUIDELINES). Am J Health-Syst Pharm 1996; 53:1669-1685.

BRISTOL LABORATORIES®

ONCOLOGY PRODUCTS

A Bristol-Myers Squibb Company

Princeton, NJ 08543

U.S.A.

Made in Italy
June 1998

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